Century Medical, a Japanese medical device distributor, has sought clearance from the country's Pharmaceuticals and Medical Devices Agency (PMDA) for Cardica's MicroCutter XCHANGE 30 cutting and stapling cartridge, which is intended for laparoscopic procedures.
The submission to the regulatory agency includes design, validation and verification data for the MicroCutter XCHANGE 30 cartridges.
The cartridges are used along with XCHANGE 30 device to carry out surgical operations.
The device features a cross-sectional area six times smaller than conventional staplers, and articulates up to 80 degrees.
It uses reloadable cartridges with a 30mm staple line length.
Laparoscopic procedures are primarily performed through 5 to 10mm trocars ports. However, in order to accommodate conventional stapling technology, surgeons are forced to use 12 or 15mm trocars, which can result in high post-operative pain, port site infection or ventral hernias.
Such complications can prolong surgical time, delay discharge, and also cause unnecessary hospital readmissions.
The smaller cross-sectional area, diameter and higher articulation of the XCHANGE 30 platform enable easier access through smaller, less-invasive ports, and allow quicker and easier access to vital organs and tissue for laparoscopic procedures.
Century Medical CEO and president Akira Hoshino said that the MicroCutter XCHANGE 30, with its small size and maneuverability, offers surgeons a significant advantage over conventional staplers.
"We anticipate launching this revolutionary device in Japan during 2014."
Cardica CEO, president Bernard A Hausen noted that Century Medical is an ideal partner for Cardica in Japan, with surgical stapling expertise and product familiarity as the exclusive Japanese distributor for the PAS-Port Proximal Anastomosis System.
"We anticipate that Japan will become an important market for the MicroCutter XCHANGE 30 due to the focus of Japanese surgeons on less invasive procedures," Hausen added.
Cardica’s MicroCutter XCHANGE 30 is currently available at select centers in Europe.